Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00093210

Purpose

The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.

Condition	Intervention	Phase
Hemophilia B	Drug: rFIX Drug: rFIX-R	Phase III

Genetics Home Reference related topics: hemophilia L1 syndrome

Drug Information available for: Factor IX

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C≤2%) Hemophilia B

Further study details as provided by Wyeth:

Study Completion Date:

September 2005

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Moderate to severe hemophilia B (FIX: C ≤2%)
Previously treated patients (PTPs) with ≥150 documented exposure days
Age ≥ 12 years (US sites only)

Exclusion Criteria:

Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)
Patient history of factor IX inhibitor replacement therapy
Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093210

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Study ID Numbers:	3090A1-304
Study First Received:	October 4, 2004
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00093210
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 14, 2009